FDA.reportPublic FDA data

Application 012616

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
004ALDACTAZIDEHYDROCHLOROTHIAZIDE; SPIRONOLACTONETABLET;ORAL25MG;25MGYesNo
005ALDACTAZIDEHYDROCHLOROTHIAZIDE; SPIRONOLACTONETABLET;ORAL50MG;50MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazideG.D. Searle LLC Division of Pfizer IncNDACurrent
59762-5014Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5014Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5014Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5014Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5014Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
66993-188Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-188Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-188Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-188Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84180SUPPL 2025-11-18
84178SUPPL 2025-11-17
72972SUPPL2022-12-21
72970SUPPL2022-12-21
66323SUPPL2021-02-23
66316SUPPL2021-02-22
64435SUPPL2020-08-27
64388SUPPL2020-08-24
57249SUPPL2019-01-18
57247SUPPL2019-01-18
10818SUPPL2014-10-24
33089SUPPL2014-03-07
12026SUPPL2014-03-07
33088SUPPL2014-01-22
12025SUPPL2014-01-21
10817SUPPL2013-06-18
12024SUPPL2013-06-13
12023SUPPL2011-09-26
12022SUPPL2011-05-24
10816SUPPL2011-05-23